The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.
Adults ≥ 18 years.
Diagnosis of T2D for at least 12 months prior to the day of screening.
Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits.
Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial
Pregnancy or breastfeeding.
Major surgery is planned during the trial period.
Cancer diagnosis within five years prior to inclusion.
Participation in other interventional trials.
Parallel
Intelligent telemonitoring
DeviceTelemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
Telemonitoring
DeviceTelemonitoring using CGM, insulin pen data, and Fitbit data
CGM time in range
Change in CGM time in range (3,9-10,0 mmol/L)
Concentration of HbA1c
Change in HbA1c
CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)
Change in CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)
CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Change in CGM time in level 2 hypoglycemia (\<3.0 mmol/L)
CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L)
Change in CGM time above range (10.1-13.9 mmol/L)
Self-reported adherence
Self-reported adherence insights from contacts between hospital staff and patients during the trial in the telemonitoring groups. Topics of conversation related to self-reported adherence will be collected based on predefined themes (e.g., missing basal dose due to forgetfulness, varying basal insulin dose during a week due to error on smartpen).
Insulin doses
Any differences in the use of insulin in terms of dosing between the three groups are examined based on data from the insulin pens, e.g., differences in the amount of insulin taken per patient (measured by units per insulin type), and differences in change in insulin dose during the trial period (measured by units).
Insulin dosing time
Any differences in the use of insulin in terms of timing of the dosing between the three groups are examined based on data from the insulin pens, e.g., differences in injection patterns.
Number of CGM days worn
Number of days that the subjects wear the CGM
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